Phase 3 study of Nexavar for the treatment of non-responsive thyroid cancer

NEXAVAR (sorafenib) 200mg tablets from Bayer and Onyx

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced the initiation of patient enrollment in their DECISION study, a Phase 3 trial to evaluate Nexavar (sorafenib tablets) for the treatment of patients with iodine-refractory, locally advanced or metastatic differentiated thyroid cancer. This international, multicenter, randomized, placebo-controlled study will enroll approximately 400 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular and Hurthle cell) who have received no prior systemic therapy. The primary endpoint is progression-free survival as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints include overall survival, time to progression and response rate. The safety and tolerability of Nexavar will also be assessed.

Nexavar is a multikinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation and angiogenesis. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is already indicated for the treatment of advanced renal cell carcinoma and unresectable hepatocellular carcinoma.